Internal Audit questions for Statistical Process Control and Process Control

[tmoney]

Good morning all. This is my first post to this forum. I am new to the Quality Control system. I am the Quality/Document Control person at my company. I am responsible for conducting the audits. I have had training and am a certified lead auditor but have only completed 2 audits. I read the interanl auditing forum for Top Management and was very impressed with the help received. I was wondering if you could do the same for me. I have an internal audit on Thursday for Statistical process Control and Process control and am at a loss. What kinds of questions do you ask reagrding these two processes. I am auditing Design and development and thought I can also cover these two processes during this audit. Does anyone have any sample questions they can share with a newly appointed auditor? We are auditing to ISO & Mil 883. Any help would be greatly appreciated. Thanks in advance

Terri

 

[RoxaneB]

Good morning all. This is my first post to this forum. I am new to the Quality Control system. I am the Quality/Document Control person at my company. I am responsible for conducting the audits. I have had training and am a certified lead auditor but have only completed 2 audits. I read the interanl auditing forum for Top Management and was very impressed with the help received. I was wondering if you could do the same for me. I have an internal audit on Thursday for Statistical process Control and Process control and am at a loss. What kinds of questions do you ask reagrding these two processes. I am auditing Design and development and thought I can also cover these two processes during this audit. Does anyone have any sample questions they can share with a newly appointed auditor? We are auditing to ISO & Mil 883. Any help would be greatly appreciated. Thanks in advance

Terri

Terri:

If I may ask, why are you auditing SPC within Design and Development? I do not know your organization, but this does not strike me as a natural fit.

I am a strong a believer in the use of matrices. All company processes (or departments) go along one axis. All (sub) clauses go along the other axis. From there we show the relationship between the processes and the clauses. I will admit that I do not see a strong relationship between our Engineering process and Data Analysis.

Under Process Control, I would focus on how they control what they do in order to meet their (internal) customers' needs. How do they select contractors. How do they handle document/drawing revisions? How do they handle technological upgrades? Project management? And so on.

Data Analysis has strong links to manufacturing and quality processes, as well as planning and management review (depending on how strong your company's strategic processes are).

 

[AndyN]

Terri,

To answer you needs way more questions of you, first! Why are you auditing SPC? Process Control can be achieved by SPC, more likely more things need to be considered, though.

Like Roaxanne, I also need to know if you are anticipating doing D & D at the same time as 'SPC' and 'Process Control'. These look to me to be exclusive audits. You say you're a certified Lead Auditor, which I take to mean that you went to a class and got a certificate? Being a certified Lead Auditor normally means being certified by RABQSA, which would mean doing much more than 2 audits!

Are you responsible for the audit program? Can you share that (schedule) with us, by 'sanitizing' it and posting it here?

 

[bobdoering]

I agree, these sure seem like two audits. For SPC, you need to determine if they have a Process, which covers how they determine which characteristics are controlled via SPC, how they determine the appropriate statistical control - variable, attribute, X-bar-R, X-median-R, etc.? Ask if they do a capability study to determine the process variation and its distribution prior to instituting a chart - or do they just "rubber stamp" an x-bar-R chart all over the plant? What is the output? What decisions are affected by the charts - process adjustments, corrective actions, etc.? Are they used correctly and followed up with in a reasonable time, or transformed into projects for deeper investigation? What happens to the charts? Are they ever verified for process issues, or data veracity?

And, of course, for any precision machining operations have all of the x-bar-R charts been eliminated?

 

[tmoney]

I thought I could kill 2 birds with one stone which seeing from the replys I can't. We had a consultant come in last year and created the program and D&D, Process Control & SPC was scheduled for an audit tomorrow. We are a Design & Development company that outsoricies manufacturing. We do some testing here. I did an audit on what production we do have & QA. We actually did look at the SPC data used on our outsourced manufacturing assembly house (CPK data) & our test house.
Yes I was certified by taking a lead auditor training class, took a test and past. I know on hand training is much more useful then taking a class.

Terri

 

[AndyN]

I thought I could kill 2 birds with one stone which seeing from the replys I can't. We had a consultant come in last year and created the program and D&D, Process Control & SPC was scheduled for an audit tomorrow. We are a Design & Development company that outsoricies manufacturing. We do some testing here. I did an audit on what production we do have & QA. We actually did look at the SPC data used on our outsourced manufacturing assembly house (CPK data) & our test house.
Yes I was certified by taking a lead auditor training class, took a test and past. I know on hand training is much more useful then taking a class.

Terri

I have no idea what your consultant was thinking! If you look at your suppliers' SPC, that's not an audit, well not in the terms of an internal quality system audit. Does your test organization do SPC? Normally testing generates data, but I've never seen them use SPC - it's a bit late! I think you might need to revisit you audit schedule/program. Post it here, lets take a look at it! Tell us a bit more about your organization so we know what you do etc. It seems to me as if you've got an 'old' approach to audits (left as a legacy) and you need to do something different to be effective!

Sorry to bring bad news! And well done on passing the course!

 

[RoxaneB]

Terri:

What processes does your organization have where SPC or analysis of data is conducted?

The idea of SPC I have applied to the cpk charts in QC that demonstrate our ability to maintain control of our manufacturing processes.

We also use data analysis based on the results of our process metrics. This demonstrates stability within our routine processes and allows to determine areas for improvement.

Did the consultant's schedule or notes leave instructions on what was meant by SPC (i.e., examples of organization processes to audit)?

 

[tmoney]

It looks like I have a lot to learn. Our consultant is a firm believer of SPC but maybe I am confusing SPC and Data analysis. Our SPC Work Instructions covers Development requirements (FMEA), SPC for our manufacturing processes (CPK) & Wafer Fabrication, Electrical test (statistical analysis of yield variances, shipping (on time delivery), QA data (LTPD Sampling Ri & FG, Supplier Data, Visual Inspection), etc.
For some reason I am unable to attach the audit schedule. Here is part of it.

8.2.3 Statistical Process Control Jan. 20&21,09Rescheduled to Feb. 5, 20096.3 Infrastructural Processes Jan. 20&21,09Rescheduled to Feb. 5, 20098.2.3 Process Control Jan. 20&21,09Rescheduled to Feb. 5, 20097.3 Design & Development Jan. 20&21,09Rescheduled to Feb. 5, 20097.3.7 Design & Development Changes Jan. 20&21,09Rescheduled to Feb. 5, 20097.3.7 Product/Process Control Notification Jan. 20&21,09Rescheduled to Feb. 5, 2009

Thanks,
Terri

 

[RoxaneB]

Terri - You will be unable to attach files until you have posted a certain number of times (I think it's 5).

 

[RoxaneB]

Terri:

I say this will the utmost respect...if you are now responsible for the audit process, what is stopping you from creating a more meaningful audit schedule? It's not a lot of work - but it will help you to get a better understand of the processes at the company, how they relate to and support each other and will bring more value to your audits.

Just my thoughts...